Q1 - JE Part B

Routine clinical service provided in a clinical research study that is in an approved clinical research study

Correct Use

• When a routine clinical service is performed as part of an approved clinical research study
  • Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study
  • Used for direct patient management within the study
  • Does not meet definition of investigational clinical services
  • Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent), clinically appropriate monitoring, whether or not required by investigational clinical service (e.g., blood tests to measure tumor markers) and items or services required for prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function)

Incorrect Use

• When service is not part of an approved clinical research study

Resources

• CMS Clinical Trial Policies
• National Coverage Determination for Routine Costs in Clinical Trials (310.1)
• CMS Medicare Learning Network (MLN) Matters (MM)5805
• CMS Change Request (CR) 7012
• CR 8401